CN106139366B

CN106139366B - Device for delivering a medical device to a heart valve

Info

Publication number: CN106139366B
Application number: CN201610459051.XA
Authority: CN
Inventors: E.克拉比奇勒
Original assignee: 伊索医疗公司
Current assignee: Aesop Medical Inc
Priority date: 2011-05-08
Filing date: 2012-05-07
Publication date: 2021-01-08
Anticipated expiration: 2032-05-07
Also published as: US10835362B2; CN103717178A; ZA201308842B; AU2012269360A1; US20140228942A1; EP2946751A1; AU2012252466B2; JP5607276B2; US20220387162A1; US20210022844A1; CA2873567A1; JP2014519370A; CN103717178B; CN103841921A; CA2836733C; EP2522307B1; WO2012152761A2; EP2522307A1; US20140194920A1; IL229330A0

Abstract

A catheter device for transvascular delivery of a medical device to a heart valve region of a patient is disclosed. The catheter device comprises an elongate sleeve (2), the elongate sleeve (2) having a releasable locking member for controllably locking the elongate sleeve in shape at least partially along its length from a relaxed state to a locked state when positioned relative to a heart valve. Furthermore, an alignment member (5) is provided to achieve a desired positioning relative to the heart valve. Embolic protection (8) is also provided.

Description

Device for delivering a medical device to a heart valve

The present application is a divisional application of the invention patent application having application number 201280033969.8, application date 2012, 5/7, entitled "device for delivering a medical device to a heart valve".

Technical Field

The present invention relates generally to the field of medical devices. In particular, the present invention relates to the positioning and procedure of catheters for delivering medical devices, and more particularly to the transvascular delivery of medical devices to heart valves.

Background

The human heart is a hollow muscular organ responsible for pumping large volumes of blood throughout the body on a daily basis. The ability to pump blood is facilitated by several heart valves that open and close appropriately to allow blood to pass through the heart. Cardiac valve insufficiency due to congenital defects or increased incidence of heart disease often requires treatment of the valve for insufficiency, where the primary treatment is mechanical adjustment of the valve or complete replacement of the valve. The current medical technology is intended to move from open major cardiac surgery, which is severely traumatic to the patient, to more minimally invasive catheter-based surgery, which is a less traumatic, but more complex procedure.

Catheter-based procedures require precise positioning of the catheter used to deliver, for example, a replacement valve, at an optimal location relative to the heart valve to be treated. This is particularly important when misalignment has the potential to damage adjacent cardiac structures, resulting in serious coronary complications. The placement of the catheter adjacent the heart valve is hindered by the fact that the heart continues to pump throughout the procedure, creating a significant level of turbulence that the catheter must overcome to maintain its position. In addition, clotting of the blood leading to emboli is a continuing threat as it potentially leads to serious complications such as stroke.

In us patent application 2009/0030510a1, it is disclosed that a significant obstacle to replacing the aortic valve is the accurate placement of a medical device for replacing the aortic valve. The solution taught to this problem is a Temporary Aortic Valve (TAV) device. This is a catheter with multiple balloons at the distal end that can be inflated to stabilize the position of the TAV by applying pressure directly to the aortic wall of the patient. In addition, the valve adjustment tool can be passed through the lumen of the TAV. Blood is allowed to pass between the balloons to simulate aortic valve function. The device is designed for ablation and replacement of the aortic valve, wherein the balloon of the TAV is inflated throughout the procedure to facilitate storage against the arterial wall.

The balloon is inflated throughout the medical procedure. This potentially causes a number of undesirable problems as the balloon obstructs blood flow by limiting the available cross-section for blood flow to the aortic lumen. For example, the amount of deliverable blood during surgery can be reduced with potentially dire consequences to the patient. Upstream of the restriction formed by the inflated balloon, blood pressure may increase. When the balloon is inflated in the aortic lumen for a long time, it may dislocate, for example, due to increased blood pressure upstream thereof.

WO 2006/029370 and US 2009/0287182 disclose expandable transluminal catheters. The distal end of the cannula remains in the first low cross-sectional configuration during advancement through the atrial septum to the left atrium. The distal end of the cannula is inflated using a radial dilator (balloon) to dilate the hole in the tissue of the atrial septum. The problem is that the device is not stable enough for a secure positioning. The radial expansion is merely to allow the hole to heal more thoroughly, rather than cutting a large hole from the outset.

US2005/0085842 discloses an expandable guide sleeve. The sleeve is advanced into the blood vessel in a contracted state and expanded to an expanded state to define a lumen. The inflated lumen is used to deliver fluids or instruments. Also in this prior art, the problem is that the device is not sufficiently stable for a secure positioning.

Accordingly, improved or alternative medical devices and procedures for stabilizing an introducer sheath during heart valve replacement would be advantageous, particularly to impart increased cost-effectiveness and/or patient safety.

Disclosure of Invention

Accordingly, embodiments of the present invention preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a medical device and a method according to the appended patent claims of the invention.

The present invention is an introducer sheath that overcomes the positioning problems faced by existing catheters by using a locking system that locks the catheter to hold it in the desired anatomical position. In addition to maintaining position, the present invention is designed to minimize obstruction to blood flow and provides for deployment of an embolic capture device to reduce the risk of embolism, for example, by debris from the treatment of stenotic valves.

According to a first aspect, a catheter device for transvascular delivery of a medical device to a heart valve region of a patient is provided. The catheter device includes: an elongate cannula having a lumen and a distal end; and an elongate member having a distal end portion comprising a plurality of radially expandable cells, wherein the elongate member is retractably insertable within the lumen, the expandable cells being arranged for temporarily positioning the elongate sleeve relative to the heart valve. The elongate sleeve comprises a releasable locking member for controllably locking the elongate sleeve in shape from a relaxed state to a locked state at least partially along its length when positioned relative to the heart valve by the expandable unit.

In a second aspect, a method of transvascularly delivering a medical device to a heart valve of a patient is provided. The method comprises the following steps: providing a catheter comprising an elongated cannula having a lumen in a relaxed state and minimally invasively guiding the catheter into the vasculature; navigating a distal end of the elongate cannula through the vasculature to the heart valve; inserting the elongate member having a distal end portion comprising a plurality of radially expandable cells into the lumen of the elongate cannula; advancing the elongate member through the elongate cannula to the distal end of the elongate cannula; radially expanding the expandable unit to temporarily position the elongate sheath relative to the valve; releasing a locking member of the catheter to maintain the elongate cannula in a locked state; retracting the expandable unit and withdrawing the elongate member from the lumen of the elongate sheath; delivering a medical device to the heart valve through the lumen of the locked elongate sheath; releasing the locking member to return the elongate cannula to the relaxed state; and withdrawing the elongate cannula from the patient's vasculature in the relaxed state.

Further embodiments of the invention are defined in the dependent claims, wherein features for the second and subsequent aspects of the invention have been made mutatis mutandis to the first aspect.

It should be emphasized that the term "comprises/comprising" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

Drawings

These and other aspects, features and advantages which can be achieved by embodiments of the present invention will become apparent from and elucidated with reference to the following description of embodiments of the invention, with reference to the accompanying drawings, in which:

FIG. 1A is a schematic view of an elongate cannula connected to a hemostatic valve;

FIG. 1B is a schematic view of an elongate member having radially expandable units in a collapsed configuration;

FIG. 2A is a schematic view of a distal end portion of an elongate member having radially expandable units in a collapsed configuration;

FIG. 2B is a schematic view of a distal end portion of an elongate member having radially expandable units in an expanded configuration;

fig. 2C is a schematic front view of a distal end portion of an elongate member having radially expandable units in a collapsed configuration;

FIG. 2D is a schematic front view of a distal end portion of an elongate member having radially expandable units in an expanded configuration;

3A, 3B, 3C, 3D are schematic views of an embodiment of an elongate cannula in a flexible unlocked configuration;

FIG. 3E is a schematic illustration of a cross-sectional view of the elongate cannula in an unlocked state;

FIG. 3F is a schematic view of one embodiment of a cross-sectional view of an elongate cannula in a locked state;

FIG. 3G is a schematic view of another embodiment of a cross-sectional view of an elongate cannula in a locked state;

FIG. 4A is a schematic view of an elongated cannula for transaxillary (transaxillary) delivery to a heart valve with an embolic protection filter deployed and the cannula in a relaxed state;

FIG. 4B is a schematic view with a relaxed sleeve positioned relative to a heart valve by an expandable unit of an elongate member extending outside a distal end of the sleeve;

FIG. 4C is a schematic illustration of a cross-sectional view of an elongate cannula employing a second passageway for delivery of an embolic protection filter;

FIG. 4D is a schematic view of an elongate sheath delivered transaxillary to a heart valve with the sheath in a locked configuration for placement relative to an aortic heart valve and with the expandable unit withdrawn after positioning of the sheath;

fig. 4E is a schematic view of an elongate sheath delivered to a heart valve via the femoral artery (transfemorally), with an embolic protection filter deployed and the sheath in a locked configuration;

FIG. 4F is a schematic view of an elongate sleeve delivered transaxillary to a heart valve, and wherein the relaxed sleeve is positioned relative to the heart valve by an expandable unit of the sleeve;

fig. 4G is a schematic view of an elongate cannula delivered transaxillary to a heart valve, and wherein an embolic protection filter is deployed over a blood vessel in the aortic arch via a second passageway of the cannula;

fig. 4H is a schematic view of an elongate cannula being delivered trans-femoral to a heart valve and with an embolic protection filter deployed over a blood vessel in the aortic arch via a second passageway of the cannula; and

fig. 5 is a flow chart of a method of implanting a medical device.

Detailed Description

Specific embodiments of the present invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbering represents like elements.

In an embodiment of the invention according to fig. 1A, a catheter device 1 for transvascular delivery of a medical device to a heart valve region 6 (see e.g. fig. 4D) of a patient is shown. The catheter device comprises an elongate cannula 2 having a lumen and a distal end 3. Furthermore, in fig. 1B, the elongate member 4 is provided with a distal end portion 9 comprising a plurality of radially expandable cells 5. The end 9 may comprise an obturator. The expandable unit 5 is arranged for temporarily positioning the elongate sheath 2 relative to the heart valve 6, see fig. 4B and 4F. The elongate member 4 is retractably insertable into the lumen of the elongate sleeve 2, and the elongate sleeve 2 comprises a releasable locking member for controllably locking the shape of the elongate sleeve 2 at least partially along its length from a relaxed state (see fig. 3B and 4A-B, 4F) to a locked state (see fig. 3C-D and 4D-E, 4G-H) when positioned by the expandable unit 5 relative to the heart valve 6.

The elongate cannula 2 depicted in fig. 1A is designed to be capable of transvascular delivery in a relaxed state, which facilitates optimal flexibility in delivery through the vasculature. When in the desired anatomical position, the elongate sheath 2, when positioned by said expandable unit 5 relative to the heart valve 6 (as can be seen in fig. 4D-E), can be transferred from the relaxed state to the locked state by actuation of the locking member, which facilitates optimal stabilization of the catheter 1 for subsequent fixation of the medical device to the heart valve 6.

Fig. 4A shows the elongate cannula inserted in its relaxed shape. Fig. 4B shows the radially expandable unit 5 in its expanded configuration (i.e. outside the elongate sheath 2), which positions the elongate sheath 2 centrally over the valve 6. The expandable unit 5 is expanded outside the elongate member 4, the elongate member 4 extending beyond the distal end of the cannula 2. The elongate sleeve 2 is then in its locked state by the locking member and the elongate member 4 can be retracted from the lumen of the elongate sleeve 2 together with the collapsed plurality of radially expandable units 5, as can be seen in fig. 4D-E. The sleeve 2 is now positioned and stabilized over the valve 6. This overcomes the problem of lack of stability and precision positioning in the prior art. Merely providing an expandable catheter does not provide as much stability as the locking member of the cannula 2. Expandable catheters have another use, namely, to provide an accessible lumen or to dilate a septum perforation. Furthermore, the expandable member of the previous catheter is only used to provide the expansion described above, and not to center the catheter over the valve as provided by the catheter 1. When the elongate sleeve 2 is locked and when the elongate member 4 is retracted, the lumen of the elongate sleeve 2 is accessible for delivering a medical device to the region of the heart valve 6.

Alternatively or in addition, an inflatable unit, such as a balloon, may be arranged on the outside of the cannula 2. The expandable unit may be integrally formed with the casing, as can be seen in fig. 4F. Thus, the expandable unit does not affect the cross section of the lumen of the cannula 2. Upon returning to the unexpanded state, delivery of the medical device through the lumen of the catheter can be achieved without the need to retract the expandable cell 5, for example by deflating a balloon of the expandable cell 5.

The expandable unit allows a defined positioning of the distal end of the catheter sleeve 2 in relation to the heart valve in an anatomical structure such as a blood vessel, an atrium or a heart chamber. This allows for accurate delivery of the medical device through the catheter device.

The movement of certain anatomical structures is very limited during the cardiac cycle. For example, the aortic arch is relatively stable and the locked catheter will remain approximately in the same spatial orientation, direction and distance to the heart valve as during the final positioning provided by the expanded expandable unit 5.

The catheter may thus be positioned in the anatomy relative to the heart valve.

The catheter may be locked in a locked configuration along its entire length. Alternatively, the catheter may be locked only along its distal end. The distal portion may be, for example, a portion disposed in the ascending aorta, the aortic arch, and the descending aorta, as shown in fig. 4E. The catheter may comprise an embolic protection unit 8, such as an embolic protection filter 8. The embolic protection unit 8 can also help stabilize the distal end of the locked catheter in place relative to the heart valve when protruding out of the second lumen 7 and being apposed against the surrounding vessel wall. Thus, when the embolic protection unit 8 is expanded, it will act as an anchor for the cannula, as it prevents the cannula 2 from moving in the aortic arch due to the fixation of the second channel 7 to the cannula, where the embolic protection unit is expanded from the second channel 7. The delivery unit 13 for the embolic protection unit 8 is sufficiently rigid to give the cannula 2 an anchoring function.

Fig. 4D is a schematic view of an elongate cannula delivered transaxillary to a heart valve, here the aortic valve 6. The embolic protection filter 8 is deployed and the sleeve 2 is in a locked configuration disposed relative to the aortic heart valve 6.

Fig. 4E is a schematic view of an elongate sleeve being delivered trans-femoral to a heart valve with an embolic protection filter deployed and the sleeve in a locked configuration.

In fig. 4D and 4E, the expandable units 5 are not shown as they are either retracted from the cannula or returned to their unnoticeable unexpanded/collapsed configuration in the cannula.

In fig. 4G-H, the embolic protection filter 8 is positioned over two or three vessels, respectively, in the aortic arch.

In all configurations shown in fig. 4A-B, 4D-H, the side vessel 22 is effectively protected from embolic particles entering from the aortic arch. Embolic particles are carried with the blood flow over the embolic protection device along the aortic arch to anatomical structures that are less sensitive than the site (e.g., brain) to which some of the side vessels 22 direct the blood flow. The embolic protection unit may be a filter unit in which embolic particles are trapped. Alternatively or in addition, the embolic protection unit may allow particles to slide along the protection unit, but not pass through or be secured therein.

In embodiments such as shown in fig. 4A-H, a catheter 1 is depicted having a second channel 7, the second channel 7 extending in parallel on the outside or inside of the elongate cannula 2.

This channel 7 allows for the delivery of additional elements, such as an embolic protection device 8 or fluids to assist in the procedure for placement of the medical device, when the lumen of the elongate cannula 2 is used for the elongate member 4 or medical device.

The second channel 7 may be an integral part on the inside or outside of the elongated cannula 2. This has the advantage of being relatively inexpensive to manufacture by an extrusion process.

In fig. 4A-H, an embodiment of an expandable embolic filter 8 is depicted. The embolic protection or filtration device 8 can be extended before extending the expandable unit 5. This potentially enhances patient safety by capturing any emboli such as platelet debris resulting from the treatment of stenotic valves, and thereby reduces the potential for serious complications such as stroke. In these figures, at least a portion of expandable embolic filter 8 extends from the aperture of side passage 7 through which embolic filter 8 passes. The embolic filter may be of the type disclosed in WO 2010/026240, which is incorporated herein by reference in its entirety for various purposes. The embolic filter unit can be non-tubular and extend substantially flat in the expanded state. This provides a compact device and effectively prevents emboli from entering the side branch vessels in the aortic arch. Interaction with the side walls in the aortic arch is thus also kept to a minimum, avoiding scraping off more debris that would be transported in the blood stream. At the same time, the aortic arch remains open for unobstructed navigation of the cannula 2. The hoop basket in previous devices scrapes the vessel wall and occludes a substantial portion of the navigation space in the aortic arch.

In this context, "flat" extension means that the thickness of the device is significantly less than its longitudinal extension. Furthermore, "flat" refers to a dimension extending perpendicular to the longitudinal direction of the protective material such that blood flow through the aortic arch is not impeded by the protective device.

By having a second passage in the cannula 2, the distal end of the cannula can be properly positioned at the valve by the stabilizing and anchoring effect of the protection unit 8 extending from the second passage, while the medical device can be delivered through the lumen of the cannula without any obstruction by the protection unit 8 or e.g. an expandable unit such as a balloon, while protecting the side branch vessels of the aortic arch from emboli possibly delivered in the blood flow resulting from the surgery performed at the valve.

The catheter device 1 may comprise a delivery unit 13 connectable to the embolic filter unit 8 at a connection point 14, as shown in fig. 4G-H. The connection point 14 is arranged eccentrically at the embolic filter unit so that the delivery unit 13 can be connected eccentrically to the embolic filter unit 8. The eccentric positioning of the embolic filter unit is advantageous for deploying it through the delivery unit 13 using the cannula 2, while effectively protecting the carotid artery from emboli when the intervention is performed. Blood flow is effectively maintained unobstructed by such a compact device. The term "eccentric" as used in the context of the present application means not in the exact middle or arranged or positioned at the center. The center is, for example, the center of a circular cell, the focal point of an elliptical cell, a point on a centerline, such as the longitudinal centerline of an elongated cell, or the like. The periphery of the cell is positioned "off-center" because it is disposed at a distance relative to the center of the cell.

The elongate member 4 may be comprised of three balloons positioned radially about the longitudinal axis at equal intervals (see fig. 2C and 2D). There may be fewer or more balloons, and alternative expansion units such as expandable mechanical levers, or swelling units such as retractable sponges. The expansion unit 5 allows an optimal positioning of the elongated sleeve 2 with respect to the heart valve 6 as described above. The multi-balloon inflation unit may be inflated using various means (see fig. 2D), such as using fluidic means or, where appropriate, gas means. The balloons may also be inflated and inflated to different pressures, independently of the other inflation cells, either individually or simultaneously.

Alternatively, the elongate member 4 is retractably inserted into the lumen of the elongate cannula 2 for a length equal to the distance between the distal end 9 and the second proximal marker 10. In this embodiment, the

proximal markers

10 and 11 are used to guide the positioning orientation of the distal end portion 9 and thus provide optimal alignment of the expandable unit 5 with the portion of the elongate sheath 2 to be expanded. This facilitates safe positioning at the desired valve area.

In another embodiment, the elongate cannula 2 is constructed of a radiopaque material to facilitate visualization of the elongate cannula 2, which provides optimal positioning of the elongate cannula 2 for delivery of the medical device. Alternatively, radiopaque fiducial markers on the elongate cannula 2 may be used for optimal positioning of the cannula 2 within the patient.

The embodiment shown in fig. 2A and 2B includes a guide wire 12, with the guide wire 12 being positioned first within the patient's body, which facilitates optimal delivery of the elongate cannula 2 and elongate member 4 to the desired anatomical location.

In the embodiment of fig. 3-4, the locking unit may comprise a releasable latch, but any form of pull wire, pressing mechanism or the like is conceivable, which serves to lock the elongated cannula 2 in a locked state, i.e. a rigid or semi-rigid state of the cannula, which state allows the cannula 2 to maintain a certain curvature, i.e. reduce the flexibility, and thereby fix its position relative to the anatomical structure, see e.g. fig. 4D-E. Furthermore, the thermal, electrical, magnetic or chemical properties of the material of the locking unit or the elongate cannula 2 itself may provide varying flexibility to change between the locked state and the relaxed state.

In particular embodiments, the elongate cannula is expandable when in the locked configuration. When the elongate cannula 2 is in the expanded state, release of the locking unit locks the elongate cannula 2 in the expanded state and thus maintains the optimal position of the surgically positioned medical device.

The locked elongate sleeve 2 may be used during a medical procedure to deliver a medical device to the heart valve 6, which may include a prosthetic heart valve prosthesis, an annuloplasty device, or a mitral valve clip.

The elongate cannula 2 may be an integral part of a medical system designed for transvascular delivery of a medical device to a heart valve 6 of a patient. The method depicted in fig. 5 first comprises 100 minimally invasively guiding a catheter 1 comprising an elongated cannula 2 with a lumen in a relaxed state into the vasculature of a patient via the femoral artery (see fig. 4E) or via the axillary route (see fig. 4D). Step 110 involves navigating the distal end 3 of the elongate cannula 2 through the vasculature to the desired heart valve, see fig. 4A. The next step 120 in the system involves inserting the elongate member 4 having the distal end portion 9 comprising the plurality of radially expandable units 5 into the lumen of the elongate cannula 2, after which the elongate member 4 is advanced through the elongate cannula 2 to the distal end of the elongate cannula 2, see fig. 4B.

Alternatively, the expandable unit 5 of the casing may be expanded at this stage (without introducing the elongate member 4 into the casing, see fig. 4F). Thereafter, a step 130 is initiated involving a plurality of radially expandable units 5 being radially expanded to temporarily position the elongate sheath 2 relative to the heart valve 6 (see fig. 4B and 4F).

After positioning, the locking member of the catheter is released to hold the elongate sheath 2 in the locked state (step 140). Step 150 of the system may then be performed, wherein the expandable unit 5 is then retracted and the elongate member 4 is withdrawn from the lumen of the elongate cannula 2, see fig. 4D-E. Alternatively, the expandable units 5 of the casing 2 are returned to the unexpanded state.

The embolic protection unit can then be pushed out of the second channel 7 as shown in fig. 4A-H. In this way, the side vessels are protected from embolic material, such as debris.

The medical device can now be delivered to the heart valve 6 through the lumen of the locked elongate sheath 2. This delivery is performed with high spatial accuracy. Blood flow in the lumen around the locked cannula 2 is less affected than with the inflated inflatable cell 5.

The medical device may be, for example, a heart valve repair or replacement device.

When the medical device has been delivered, release of the locking member may now be performed to return the elongate cannula 2 to the relaxed state (step 160), followed by withdrawal of the elongate cannula 2 from the vasculature of the patient in the relaxed state.

The embolic protection unit as shown in fig. 4A-H can be retracted before or after the locking member is released.

Locking the elongate sleeve 2 in the locked state (fig. 3B-D) comprises releasing the locking member when positioned by the expandable unit 5 relative to the heart valve 6 so as to controllably lock the elongate sleeve 2. This serves to maintain an optimal position for the delivery of the medical device during surgery.

To ensure optimal positioning of the elongate member 4 when inserted into the elongate cannula 2, the elongate member 4 is inserted to a length equal to the distance between the distal and proximal markers 10 of the elongate member 4. Primarily, the elongate cannula 2 will be positioned centrally with respect to the heart valve 6, which facilitates optimal delivery of the medical device, but other eccentric positions may be desirable.

The medical system is primarily used for delivering medical devices to be secured to a specific heart valve 6, including the aortic and mitral valves of a patient. After delivery of the medical device to the heart valve 6, the medical device delivery system is withdrawn through the lumen of the locked elongate sheath 2, which may be assisted when the elongate sheath 2 is in the expanded state. After removal of the medical device delivery system, the elongate cannula 2 in the locked state is transferred to the relaxed state, which facilitates facilitating retraction of the elongate cannula 2.

The invention has been described above with reference to specific embodiments. However, other embodiments than the above described are equally possible within the scope of the invention. Different method steps than those described above may be provided within the scope of the invention. The different features and steps of the invention may be combined in other combinations than those described. The catheter may be positioned and locked in other cardiac anatomies than those shown. The medical device delivered through the catheter sheath may be any medical device to be delivered to the heart valve tissue. The scope of the invention is limited only by the appended claims.

Claims

1. A catheter device (1) for transvascular delivery of a medical device to a heart valve region (6) of a patient, the heart valve region (6) comprising an aortic valve of the patient, the catheter device comprising:

an elongate cannula (2) having an exterior, a lumen, a distal end, and a distal portion, the distal end of the elongate cannula (2) being configured to be disposed in an ascending aorta and having a locked configuration; and

at least one of radially expandable units (5) for apposition with tissue luminal tissue within the aortic arch when expanded, at least one of the radially expandable units (5) being arranged on the exterior of the elongated sleeve (2) at the distal end portion, and the at least one radially expandable unit (5) being configured for positioning the elongated sleeve with its distal end in an ascending aortic portion of the aortic arch, and the distal end of the elongated sleeve (2) being configured to be oriented towards, spaced a distance downstream in the blood flow direction from, and locked and centrally positioned relative to, the aortic valve when the radially expandable unit (5) is in an expanded state.

2. The catheter device of claim 1, wherein the at least one radially expandable unit is integrally formed with the elongate sheath.

3. The catheter device of claim 1 or 2, wherein the at least one radially expandable unit comprises an inflatable balloon, an inflatable mechanical lever or a swellable unit.

4. The catheter device of claim 1 or 2, wherein the at least one radially expandable unit is a plurality of radially expandable units.

5. The catheter device of claim 4, wherein the plurality of radially expandable units are positioned equally spaced about a longitudinal axis of the elongate sheath.

6. The catheter device of claim 1 or 2, wherein the elongate sleeve comprises radiopaque fiducial markers.

7. The catheter device of claim 1 or 2, wherein the medical device is a prosthetic replacement valve or a valve repair device.

8. A kit comprising a catheter device according to any of claims 1 to 7 and a medical device for a heart valve, the medical device comprising an artificial replacement valve or a valve repair device.

9. A catheter device (1) for transvascular delivery of a medical device to a heart valve region (6) of a patient, the catheter device comprising:

an elongate cannula (2) having a lumen and a distal end, the distal end having a locked configuration; and

at least one radially expandable unit disposed at a distal end of the elongate sheath, positionable in an ascending aorta of the patient, and arranged for temporarily positioning the elongate sheath relative to the heart valve when in an expanded state;

an elongate member (4) having a distal end portion comprising a plurality of radially expandable cells (5), the elongate member being retractably insertable into the lumen;

the radially expandable unit is arranged for temporarily centering the elongate sleeve relative to the heart valve when in an expanded state outside the distal end of the locked elongate sleeve; and is

Wherein the distal end of the catheter is configured to be disposed in an ascending aorta.

10. The catheter device of claim 9, wherein the elongate member is retractable from the lumen with the plurality of radially expandable units when collapsed.